Trial · NCT04958785
Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
NCT04958785, Phase 2, Terminated, Gilead Sciences; results first posted 2025-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer. Trials, record NCT04958785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04958785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer
- NCT number
- NCT04958785
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- Magrolimab, Nab-Paclitaxel, Paclitaxel, Sacituzumab Govitecan-hziy
- First posted
- 2021-07-12
- Last updated
- 2025-11-04
- Other registries' IDs
- eudract:2021-001074-27
- Results first posted
- 2025-10-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) | First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2) | A DLT is defined as any: * Grade 3 or higher hematologic toxicity including: * Hemolytic anemia that is medically significant, requiring hospitalization or prolongation of existing hospitalization, disabling, or limiting self-care activities of daily life. * Event meeting Hy's Law criteria: * Treatment-emergent alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation (at least 3 x ULN), AND * Treatment-emergent total bilirubin elevation (more than 2 x ULN), and absence of cholestasis (defined as alkaline phosphatase less than 2 x ULN), AND * No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, alcohol ingestion, congestive heart failure, worsening liver metastases). * Grade 3 or higher nonhematologic toxicity that has worsened in severity from pretreatment baseline during the DLT assessment period, and in the opinion of the investigator, the AE is at least possibly related to magrolimab. |
| Primary | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to last dose date (up to 73 weeks) plus 30 days | TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment. |
| Primary | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | First dose date up to last dose date (up to 73 weeks) plus 30 days | Treatment-emergent laboratory abnormalities according to NCI CTCAE V5.0 are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days and prior to the day before initiation of subsequent anti-cancer therapy. Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening and Grade 5 death. Percentages were rounded off. |
| Primary | Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 107 weeks | PFS was defined as the time from the date of randomization until the earliest date of documented disease progression (PD), as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (KM) estimates were used in outcome measure analysis. |
| Primary | Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 107 weeks | ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as determined at least 4 weeks after initial documentation of response by investigator assessment per RECIST v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off. |
| Secondary | Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1 | Up to 107 weeks | ORR is defined as the percentage of participants who achieve a CR or PR that is confirmed at least 4 weeks after initial documentation of response, as measured by RECIST version 1.1, as determined by investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Clopper-Pearson estimates were used in outcome measure analysis. Percentages were rounded off. |
| Secondary | Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1 | Up to 107 weeks | PFS is defined as the time from the date of randomization until the earliest date of documented disease progression, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1 | Up to 107 weeks | DOR is defined as time from first documentation of CR or PR to the earliest date of documented PD, as determined by investigator assessment per RECIST version 1.1, or death from any cause, whichever occurs first. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Overall Survival (OS) | Up to 107 weeks | OS is defined as time from date of randomization to death from any cause. |
| Secondary | Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs | First dose date up to last dose date (up to 73 weeks) plus 30 days | TEAEs are defined as any events not present prior to the study treatment, or any events already present but worsening in either intensity or frequency following exposure to the study treatment. TEAEs were any AEs with an onset date on or after the date of the first dose of study treatment up to 30 days after the date of the last dose of study treatment, or the day before initiation of subsequent anticancer therapy, whichever comes first. An AE is any untoward medical occurrence in a clinical study patient administered a study drug that does not necessarily have a causal relationship with the treatment. Percentages were rounded-off. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) | First dose date up to 28 days (Cohort 1) and up to 21 days (Cohort 2) | DLT-Evaluable Analysis Set included all participants who meet 1 of the following criteria:~* Participant experienced a DLT at any time after initiation of the first infusion of magrolimab.~* Participant did not experience a DLT and completed at least 3 infusions of magrolimab (28-day cycle), and at least 2 doses of nab-paclitaxel or paclitaxel (Safety Run-in Cohort 1 (SRiC1)), at least 2 infusions of magrolimab (21-day cycle), and at least 2 infusions of sacituzumab govitecan (SRiC2). | percentage of participants | NUMBER |
| PRIMARY | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to last dose date (up to 73 weeks) plus 30 days | The Safety Analysis Set in the Safety Run-in Cohorts 1 and 2 included all participants who took at least 1 dose of any study drug. | percentage of participants | NUMBER |
| PRIMARY | Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | First dose date up to last dose date (up to 73 weeks) plus 30 days | Participants in the Safety Run-in Cohorts 1 and 2 in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 107 weeks | Participants from Phase 2 Cohort 1 in the Intent-to-treat (ITT) Analysis Set were analyzed. | months | MEDIAN |
| PRIMARY | Safety Run-in Cohort 2 and Phase 2 Cohort 2: Confirmed Objective Response Rate (ORR) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Up to 107 weeks | Participants in the modified Intent-To-Treat (mITT) Analysis Set (Cohort 2) were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Phase 2 Cohort 1: Confirmed ORR as Determined by Investigator Assessment Per RECIST, Version 1.1 | Up to 107 weeks | Participants from the Phase 2 Cohort 1 in the ITT Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Safety Run-in Cohort 2 and Phase 2 Cohort 2: PFS as Determined by Investigator Assessment Using RECIST Version 1.1 | Up to 107 weeks | Participants in the mITT Analysis Set (Cohort 2) were analyzed. | months | MEDIAN |
| SECONDARY | Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Duration of Response (DOR) as Determined by Investigator Assessment Per RECIST Version 1.1 | Up to 107 weeks | Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Phase 2 Cohort 1, Safety Run-in Cohort 2 and Phase 2 Cohort 2: Overall Survival (OS) | Up to 107 weeks | Participants in the ITT Analysis Set (Cohort 1) and mITT Analysis Set (Cohort 2) were analyzed. | months | MEDIAN |
| SECONDARY | Phase 2 Cohort 1 and Cohort 2: Percentage of Participants Experiencing TEAEs | First dose date up to last dose date (up to 73 weeks) plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 0 | percentage of participants | ||
| Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 0 | percentage of participants | ||
| Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 100.0 | percentage of participants | ||
| Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 100.0 | percentage of participants | ||
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | Any Grade | 100.0 | percentage of participants | |
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | Any Grade | 100.0 | percentage of participants | |
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | Grade 3 or 4 | 62.5 | percentage of participants | |
Safety Run-in Cohorts 1 and 2: Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), Version 5.0 | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | Grade 3 or 4 | 84.6 | percentage of participants | |
| Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 13.9 | 95% Confidence Interval 3.5 to NA | months | |
| Phase 2 Cohort 1: Progression-free Survival (PFS) as Determined by Investigator Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 10.0 | 95% Confidence Interval 1.0 to NA | months |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 8 | |
| Overall Study | STARTED | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 14 | |
| Overall Study | STARTED | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 14 | |
| Overall Study | STARTED | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 13 | |
| Overall Study | STARTED | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 43 | |
| Overall Study | COMPLETED | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 0 | |
| Overall Study | COMPLETED | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 0 | |
| Overall Study | COMPLETED | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 0 | |
| Overall Study | COMPLETED | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 0 | |
| Overall Study | COMPLETED | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,170
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 7 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 5 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 1 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 11 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 20 | 42 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 0 | 8 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 0 | 14 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 0 | 13 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 1 | 13 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 1 | 42 |
1 to 10 of 1,170Source ClinicalTrials.gov
See all 1,170 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 2 | 8 |
| Total, all-cause mortality | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 3 | 14 |
| Total, all-cause mortality | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 4 | 14 |
| Total, all-cause mortality | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 6 | 13 |
| Total, all-cause mortality | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 5 | 43 |
| Total, other adverse events | Safety Run-in Cohort 1: Magrolimab + Nab-Paclitaxel | 8 | 8 |
| Total, other adverse events | Phase 2 Cohort 1 Arm A: Magrolimab + Nab-Paclitaxel or Paclitaxel | 14 | 14 |
| Total, other adverse events | Phase 2 Cohort 1 Arm B: Nab-Paclitaxel or Paclitaxel | 13 | 13 |
| Total, other adverse events | Safety Run-in Cohort 2: Magrolimab + Sacituzumab Govitecan | 13 | 13 |
| Total, other adverse events | Phase 2 Cohort 2: Magrolimab + Sacituzumab Govitecan | 41 | 42 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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GET https://conductscience.org/api/trials/v1/NCT04958785/results?page=2